IKEMA: SARCLISA + Kd

IKEMA Trial:
SARCLISA + Carfilzomib and
Dexamethasone (Kd) vs Kd Alone

Evaluated in 302 patients in a phase 3, multicenter, multinational, randomized, open-label study1,2

Treatment was administered in 28-day cycles until disease progression or unacceptable toxicity.

aSARCLISA 10 mg/kg was administered as an IV infusion weekly in the first cycle and every 2 weeks thereafter.

bCarfilzomib was administered as an IV infusion during cycle 1 at a dose of 20 mg/m2 on days 1 and 2, and at 56 mg/m2 on days 8, 9, 15, and 16; during subsequent cycles, it was administered at 56 mg/m2 on days 1, 2, 8, 9, 15, and 16. Dexamethasone (IV on the days of SARCLISA and/or carfilzomib infusions, and orally on the other days) 20 mg was given on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.

CR=complete response; IV=intravenous; MRD=minimal (or measured) residual disease; ORR=overall response rate;
OS=overall survival; PFS=progression-free survival; VGPR=very good partial response.

The IKEMA trial included a broad and diverse patient population1,2

Baseline characteristics were similar across both treatment arms

Patient factors

Treatment history

Baseline characteristics
SARCLISA + Kd
(n=179)
Kd
(n=123)
Age, years
 
 
Median (range)
65 (37-86)
63 (33-90)
<65
49%
54%
65-74
41%
38%
≥75
9%
8%
Baseline eGFR (MDRD)
 
 
<60 mL/min/1.73 m2
24%
15%
ECOG PS
 
 
0 or 1
94%
96%
2
6%
4%
ISS stage at study entry
I
50%
58%
II
35%
25%
III
15%
16%
Cytogenetic risk at baseline
 
 
Higha
23%
25%
gain(1q21)b
42%
42%
Standard
64%
63%
Unknown or missing
13%
11%
Prior lines of therapyc
 
 
Median (range)
2 (1-4)
2 (1-4)
1
44%
45%
Prior therapies
 
 
PI (bortezomib)
93% (91%)
85% (83%)
IMiD® (lenalidomide)
76% (40%)
81% (48%)
Patient refractory to
 
 
IMiD (lenalidomide)
44% (32%)
47% (34%)
PI
31%
36%
IMiD + PI
20%
22%
Previous ASCT
 
 
Yes
65%
56%

aHigh-risk cytogenetic status is defined as the presence of del(17p) and/or t(4;14) and/or t(14;16). Chromosomal abnormality was considered positive if present in at least 30% of analyzed plasma cells, except for del(17p), where the threshold is at least 50%.1

bGain(1q21), was also analyzed and was considered positive if there were at least 3 copies in at least 30% of analyzed plasma cells.2

cInclusion criteria for the IKEMA study specified 1 to 3 prior lines of therapy; however, a small number of patients included in the study had received >3 prior lines of therapy (n=5/302, 1.7%).2

*PFS results were assessed by an independent response committee, based on central laboratory data for monoclonal protein, and central radiologic imaging review using the International Myeloma Working Group criteria. An interim analysis was conducted when 65% of the 159 PFS events (ie, 103 events) were observed.1,2

Impaired renal function is defined as eGFR <60 mL/min/1.73 m2.1

ASCT=autologous stem cell transplant; ECOG PS=Eastern Cooperative Oncology Group performance status; eGFR=estimated glomerular filtration rate; IMiD=immunomodulatory drug; ISS=International Staging System; MDRD=modification of diet in renal disease; PI=proteasome inhibitor.

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